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. 2011 Jul 6;2011(7):CD008122. doi: 10.1002/14651858.CD008122.pub2

Nigussie 2008b.

Clinical features and settings Presenting signs and symptoms: Acutely febrile patients
Previous treatment for malaria: No exclusions based on previous treatment; 220 participants were interviewed regarding previous antimalarial use and 24 of these (11%) reported antimalarial use in the previous month
Clinical setting: Health centre outpatient departments
Country: Ethiopia (Wondo‐Genet)
Malaria endemicity: Not stated
Malaria endemic species:P. falciparum and P. vivax
Participants Sample size: 259 received RDT, although 460 were enrolled in the study
Age: All ages eligible. Actual age range 1 to 60 years.
Sex: Males and females eligible for the study, actual numbers who received Parascreen not presented
Co‐morbidities and pregnancy: No exclusions criteria based on co‐morbidities. No details of the frequency of these conditions in the participant population is presented.
Parasite density of microscopy positive cases: Not presented
Study design Enrollment was consecutive and prospective. Two RDTs were tested in the study, these are reported separately in this review
Target condition and reference standard(s) Target condition: Malaria parasitaemia
Reference standard: Microscopy thick and thin blood films
Person(s) performing microscopy: Technicians who were members of the research team, and independent readers at a central laboratory
Microscopy setting: Health centres and Akilu Lemma Institute of Pathobiology parasitology laboratory
Number of high power fields examined before declaring negative: 100
Number of observer or repeats: Two, one at the health centre and one at the central laboratory
Resolution of discrepancies between observers: There were no discordant results
Index and comparator tests Commerical name of RDT:
Parascreen Pan/Pf (Zephyr Biomedical, Verna, Goa, India)
Parasite(s) designed to detect:P. falciparum or mixed infection, non‐falciparum species only
Designated Type: Type 3
Batch numbers: Not stated
Transport and storage conditions: Not described
Person(s) performing RDT: Two well experienced technicians who were part of the research team
RDT setting: Health centres
Follow‐up Not applicable
Notes Source of funding: The Global Fund to fight AIDS, TB and Malaria through the Federal Democratic Republic Ethiopian Ministry of Health
Table of Methodological Quality
Item Authors' judgement Description
Representative spectrum? 
 All tests Unclear Due to a shortage of test kits, only 259 of the 460 participants enrolled in the study received this RDT test, and it is not clear how these participants were selected
Acceptable reference standard? 
 All tests Yes Two independent readers viewed at least 100 high power fields before declaring a slide negative. One reader was based at a central laboratory and there were no discordant results between readers.
Partial verification avoided? 
 All tests Yes All participants who received the index test also received the reference test
Differential verification avoided? 
 All tests Yes The same reference test was used regardless of the index test results
Incorporation avoided? 
 All tests Yes The index test does not form part of the reference standard
Reference standard results blinded? 
 All tests Unclear Blinding not described
Index test results blinded? 
 All tests Unclear Blinding not described
Uninterpretable results reported? 
 All tests Yes Eight participants were excluded due either to incomplete information on either the Paracheck test or the malaria slide
Withdrawals explained? 
 All tests Yes The number of participants enrolled in the study is clearly stated and corresponds to the number presented in the analysis minus the number reported to have invalid test results or incomplete data